DelfaGLP-1 Atlas

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Active not recruitingPhase 2

A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

40

Recruiting sites

—

Enrollment

414

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥35

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06037252
Org study ID18739
Secondary ID2023-504561-24-00EU Trial Number
Secondary IDI8F-MC-GPITEli Lilly and Company

Timeline

Milestones

Study first posted2023-09-14actual
Study start2023-09-21actual
Primary completion2026-01-08actual
Last update posted2026-03-23actual
Study completion2026-10estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening.
•Have had stable body weight (±5%) during the 90 days preceding screening.
•Have been diagnosed with Type 2 Diabetes (T2D).
•Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.

Exclusion criteria

•Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
•Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.
•Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
•Have a prior or planned surgical treatment for obesity.
•Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.
•Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliter/min (mL/min)/1.73 m².
•Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.
–acute myocardial infarction.
–cerebrovascular accident (stroke).
–unstable angina .
–hospitalization due to congestive heart failure, or
–coronary artery revascularization.
•Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
•Have a history of chronic or acute pancreatitis.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
10
Glycemic / diabetes
2
Safety / tolerability / PK
1

Weight & body composition

10 endpoints
Primary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline (Week 0), Week 44

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline (Week 24), Week 80

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute Change from Baseline in Body Weight

Time frame:Baseline (Week 0), Week 44

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Absolute Change from Baseline in Body Weight

Time frame:Baseline (Week 24), Week 80

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline (Week 0), Week 44

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in BMI

Time frame:Baseline (Week 24), Week 80

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline (Week 0), Week 44

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline (Week 24), Week 80

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥15% Body Weight Reduction

Time frame:Baseline (Week 0), Week 44

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥15% Body Weight Reduction

Time frame:Baseline (Week 0), Week 80

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline (Week 0), Week 44

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline (Week 24), Week 80

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)

Time frame:Baseline through Week 44

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.